Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus

Stopped early · Phase 1/Phase 2

Conditions studied: Islets of Langerhans Transplantation, Diabetes Mellitus, Type 1

In brief

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are: * Using Two-Layer method preservation to improve pancreas quality before islet isolation * Maintaining isolated islets in culture before transplantation * Using a steroid-free immunosuppression regimen * Transplanting the best combination of donor and recipient possible after human leukocyte antigens (HLA) screening and final crossmatching

Key facts

Study ID

NCT00579371

Run by

University of Nebraska

People needed

30

Starts

2004-03-17

Expected to finish

2011-03-01

Last updated by the study team

2023-12-21

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Group 1: Diagnosis of Type-1 diabetes mellitus for more than 5 years with at least one of the following complications:
• Metabolic lability/instability (two or more episodes of severe hypoglycemia) or two or more hospital visits for diabetic ketoacidosis during the previous year
• Progression of secondary complications of diabetes as determined by The Nebraska Medical Center/University of Nebraska Medical Center staff endocrinologists
• Group 2: Diagnosis of Type-1 diabetes with successful renal transplant on steroid-free, FK506/rapamycin-based immunosuppression

You may not qualify if…

• Severe co-existing cardiac disease
• Active alcohol or substance abuse, including cigarette smoking
• Psychiatric disorder making the subject not a suitable candidate for transplantation
• History of medical non-compliance
• Active infection, including hepatitis C and B, HIV, and tuberculosis (or suspected tuberculosis)
• Any history of malignancy except squamous or basal cell skin cancer
• BMI >28 kg/meter-squared, or body weight >80kg at screening visit, or >85kg on the day of transplantation (due to the difficulty of obtaining a sufficiently large islet mass to adequately treat either large patients or those whose obesity elevates their insulin needs)
• Positive C-peptide response to intravenous glucose tolerance test and Mixed Meal glucose tolerance test: any C-peptide >0.3 ng/mL post infusion
• Inability to provide informed consent
• Age less than 19 or greater than 70 years
• Creatinine clearance <60 mL/min/1.73 meter-squared for Group 1 and creatinine clearance <40 mL/min/1.73 meter-squared for Group 2 (those subjects currently on immunosuppression due to previous kidney transplant)
• Macroalbuminuria (urinary albumin excretion rate >300 mg/24h) for Group 1 and macroalbuminuria (urinary albumin excretion rate >600mg/24h) for Group 2
• Baseline Hb <10 gm/dL
• Baseline liver function tests outside of normal range
• Presence of gallstones or hemangioma in liver on baseline ultrasound exam
• Positive pregnancy test, intention of future pregnancy, or presently breast-feeding
• Evidence of sensitization on panel reactive antibodies (PRA)
• Insulin requirement >0.7 IU/kg/day or HbA1c >15%
• Hyperlipidemia
• Under treatment for a medical condition requiring chronic use of steroids
• Use of Coumadin or other anticoagulant therapy (except aspirin) or a prothrombin time/international normalized ratio (PT-INR) >1.5
• Diagnosis of Addison's disease
• Additional Exclusion Criteria for Group 2 Subjects:
• Any history of organ transplantation other than kidney or pancreas
• Any previous graft lost to rejection

Where it is running

• The Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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